Bureaucracy Hampers an E. coli Weapon

French biotech GeneSystems developed a system to detect the deadly bacterium before it reaches supermarket shelves, but it faces red tape and resistance

On Mar. 21 French supermarket chains Carrefour (CARR.PA) and Monoprix (CASP.PA) began alerting consumers that more than two tons of ground meat infected with E. coli bacteria had been sold in stores throughout France. One of the country's top food preparation companies, Socopa, revealed that routine tests run on meat prepared on Mar. 10-11 had detected the bacterium, but its presence wasn't confirmed until Mar. 21—long enough for contaminated products to make it onto dinner plates. At least 40 people were sickened. E. coli can cause not only violent intestinal trouble, but also kidney damage or even death.

If GeneSystems has its way, such a scenario won't be allowed to happen again. The seven-year-old biotech company, based near Rennes, in France's Brittany region, claims its technology can slash the time needed to confirm the presence of E. coli in raw beef from a matter of days to just eight hours—fast enough to yank infected meat before it hits supermarket shelves.

GeneSystems, which has raised $15 million in venture capital, accomplishes this feat by doing away with traditional slow-growing Petri dish cultures, instead harnessing a molecular biology technique called polymerase chain reaction (PCR) that produces as many as 100 billion copies of a strand of DNA in a single afternoon. With a large sample to work from, lab technicians can more easily spot bacteria such as E. coli using diagnostic equipment. The company's technology also can be used to screen for Salmonella, Legionnaires' disease, and Listeria.

Benefiting a Wider Public

PCR was developed in 1983 by U.S. scientist Kary Mullis, who won a Nobel Prize for his work in 1993. It is used today to perform a wide variety of genetic tests, as well as to detect HIV, sepsis, and urinary tract infections. GeneSystems has built on the basic PCR process by marrying it with automation, so that its use is no longer limited to research or specialized tests that target a single agent.

"My vision was to try and democratize molecular biology by combining PCR with microchips," says 35-year-old French microbiologist Gabriel Festoc, GeneSystem's founder and chief scientific officer. "The wider public benefits because faster and better test results will improve food safety and reduce health risks."

Compared with any previous tests for E. coli, the solution from GeneSystems is remarkably fast and easy. It consists of a "microlaboratory" the size of a compact disc that is engraved with 36 microchambers, or tiny wells, filled with the chemical agents needed to detect and quantify multiple DNA targets. Once loaded with test material, the disc is inserted into a machine that can perform up to 12 tests simultaneously, significantly speeding results and reducing the risk of human error.

A Superior Culture

There's only one fly in the ointment—and it's a doozy. GeneSystems has run into a wall of red tape and resistance to change among public-health authorities in Europe, especially in France, who aren't ready to accept tests based on PCR. According to Darryl Spurling, the chief executive of GeneSystems, the food industry and regulators are still "deeply wedded" to slow tests using cultures grown in Petri dishes, a method first introduced in 1887.

The disadvantage of that approach was highlighted by the recent E. coli scare in France, when slow confirmation of the bacteria's presence allowed tainted meat into the food supply. But GeneSystems claims advantages other than just speed. The company's technology also is the first anywhere that can detect five of the most virulent strains of E.

coli, compared with just the one strain, called 0157, spotted by traditional culture tests using antibodies.

E. coli isn't the only menace GeneSystems can detect. In 1998, France was shaken up by an outbreak of Legionnaires' disease, a virulent pneumonia caused by the obscure Legionella bacterium that can thrive in water systems. The government passed a law requiring regular testing of cooling towers in factories and public showers—giving rise to a market for Legionella testing that tops $160 million per year.

Retailers Not Waiting for Government

The Legionella culture test takes two weeks to produce results, but GeneSystems can spot the bug in just three hours. Despite the clear public-health advantage, the company has been fighting an uphill battle since 2000 to gain acceptance for its PCR-based tests. GeneSystems is lobbying the French government to amend its law, which mandates the use of Petri cultures, but can't estimate when that may happen.

In the meantime, approval could come sooner for wider use of GeneSystems' E. coli test. The company's technology has fared well in independent evaluations conducted by national laboratories around Europe, including the German National Reference Laboratory in Berlin. But PCR can't be used Europewide in place of cultures until the EU develops a "reference test," a draft of which already has been circulated, that covers the same five strains of E. coli that GeneSystems can detect. CEO Spurling says he expects a formal reference to be adopted in 2009, at which point the company's technology will have an official green light.

GeneSystems isn't twiddling its thumbs until that happens. "Fortunately supermarkets are not going to wait for government regulation to catch up," says founder Festoc. Although it's not the legal fault of retailers if they sell contaminated meat, they have the most to lose from food scares in terms of public confidence and brand impact. GeneSystems says it expects to sign up at least one major European supermarket chain as a customer in the coming weeks.

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